Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive

Overview

In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. The technical evolvements of sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was performed in the patients with clinically negative axillary nodes. However, previous published studies concerning patients with breast cancer who all underwent a radical mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary metastases. For this reason, IM-SLNB is even more important for clinically axillary node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early breast cancer patients with clinically positive axillary nodes.

Full Title of Study: “Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2017

Detailed Description

OBJECTIVES: – Determine the impact of routinely performed internal mammary sentinel lymph node biopsy on the systemic and locoregional treatments plan. – Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node-positive. – Draw the learning curve of internal mammary sentinel lymph node biopsy. OUTLINE: 3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-labeled sulfur colloid in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5~1.0 hour before surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the internal mammary sentinel lymph nodes were sent to histologic examination.

Interventions

  • Procedure: IM-SLNB
    • IM-SLNB is performed according to the pre-operative lymphoscintigraphy
  • Radiation: 99mTc-SC
    • Two syringes of 0.25~0.5 mCi 99mTc-SC in 0.2~1.0 mL volume were injected intraparenchymally into 2 quadrants of breast, at the 6 and 12 o’clock positions.
  • Device: Histologic Examination
    • All IMSLNs were analyzed by histologic examination for future therapy planning.
  • Device: LSG
    • lymphoscintigraphy was performed 0.5~1.0 hour before surgery
  • Drug: Methylthioninium
    • Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery

Arms, Groups and Cohorts

  • Experimental: clinically positive axillary nodes
    • 3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
    • Time Frame: 1 year
    • Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB

Secondary Measures

  • Visualization Rate of IMSLNs
    • Time Frame: 1 year
    • visualization rate of internal mammary hotspots in lymphoscintigraphy
  • Metastasis Rate of IMSLNs
    • Time Frame: 1 year
    • Metastasis Rate of internal mammary sentinel lymph node

Participating in This Clinical Trial

Inclusion Criteria

  • primary breast cancer – clinically axilla-positive Exclusion Criteria:

  • enlarged internal mammary nodes by imaging

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shandong Cancer Hospital and Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yongsheng Wang, Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor – Shandong Cancer Hospital and Institute
  • Overall Official(s)
    • Yong-sheng Wang, MD, Study Chair, Shandong Cancer Hospital and Institute
    • Peng-fei Qiu, MD, Principal Investigator, Shandong Cancer Hospital and Institute
    • Yan-bing Liu, MD, Principal Investigator, Shandong Cancer Hospital and Institute

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.